Description
I have an immediate opening for a QA Engineer with strong validation experience to join rapidly growing medical device company based in Limerick. This is a 12 month hourly rate contract position.This role requires a candidate with a strong QA and validation experience, candidates with the ability to work independently and with strong initiative are highly desired.
The QA Validation Engineer will ensure that all key validation related documents are developed, executed and reviewed in accordance with GMP regulatory and corporate and internal requirements.
KEY RESPONSIBILITIES
* Review / Approval of Validation Protocols ( e.g. URS, Facility, Utility, Process, Cleaning, Test Method, and Equipment validations) to ensure compliance with current regulatory expectations, EU,FDA and Corporate Standards and Internal Procedures
* Review / Approval of Validation Reports ( e.g. URS, Facility, Utility, Process, Cleaning, Test Method, and Equipment validations) to ensure compliance with current regulatory expectations, EU,FDA and Corporate Standards and Internal Procedures
* Resolve and assist in the closure of discrepancies initiated during Qualification execution.
* Ensures that change requests and Document Change Requests are compliant with all applicable procedures. This will involve actively reviewing the CR's and the underlying documents for compliance and the ability to be understood by third party reviewers. Responsible for providing feedback to the originators, approvers, and site management.
* Develop/Review/Approve Validation Plans.
* Implement, deploy and revise as applicable Validation procedures.
* Conduct training Validation Methodologies and related procedures as required.
* Provide guidance to project teams on Validation strategy and approach.
* Generate SOP's/other documentation as applicable.
* Adherence to FDA 21 CFR Parts 600, 606, 210, 211, 820 and 11.
EDUCATION and EXPERIENCE:
* Minimum of degree qualification in relevant science and/or engineering discipline
* 3 Years minimum post educational experience with working in a regulated environment preferably within a Pharma/Biotech/Medical Devices facility.
* 5 yrs in a Validation function with strong knowledge of CSV/GAMP, 21 CFR Part 11, Project Life Cycle and cGMP Regulations.
* Have a strong working knowledge of statistical techniques in the use of problem solving/ data analysis.
* Experience of coordination of Quality documentation and in particular, qualification/Validation documentation and using an electronic document management system.
This is an excellent opportunity to join a world renowned medical device company working on a new exciting product. If you feel you are a good fit and are interested in hearing more please apply directly to this advert or contact Derek SHeridan on